Clinical Laboratories: 15 Industry Predictions in 2022
Industry experts predict a year of change and transformation ahead as the COVID-19 pandemic continues to influence the way clinical labs operate. Predictions included the continued rise in the use of AI, more at-home testing, and heavier laboratory workloads as patients catch up on missed tests.
By Chris Wolski (Article shared from Clinical Laboratories. Download article here)
The end of any calendar year is often a time to give pause to look back at where we’ve been and, more importantly, look ahead at where we’re headed.
It’s hardly an exaggeration that 2021 was both a time of significant challenges for clinical laboratories—and the entire health enterprise—but also one of opportunities as well. And while 2021 like 2020 will likely be overshadowed by the global COVID-19 pandemic, what will 2022 have in store for the industry? More of the same? Or something significantly different?
CLP asked industry leaders to weigh in on their predictions for 2022, the following 15 predictions, in no particular order, point to a year that will, once again, be filled with challenges, but some transformative trends that should be welcome news to laboratorians.
Prediction #1: Chronic or long COVID will become an increasingly important healthcare issue.
There is little doubt that COVID will continue to touch a large portion of the patient population, particularly in the aftermath of an infection.
“Chronic or Long COVID will become an increasingly important issue in healthcare in the U.S., as an estimated 10-30% of the 45 million infected with COVID—up to 13 million patients—are now COVID long haulers. Legislation is likely to be enacted to provide funding for research, testing and treatment for Long COVID patients,” says Ronald A. Blum, PhD, chief marketing officer for IncellDx and CEO of Blum & Associates Consulting.
Significantly, this will mean that the approach to testing will have to change.
“While diagnostic testing to detect the presence of COVID will continue—although at a significantly lower rate—novel testing will be needed to address the rapidly increasing number of chronic COVID patients whose immune systems have been compromised, resulting in a wide range of debilitating symptoms,” says Blum, who is also a member of CLP’s editorial advisory board. “This need represents an opportunity for IVD companies and laboratories to develop and offer specialized testing that will better identify, evaluate, stratify, and characterize long hauler patients for actionable treatment options.”
Prediction #2: COVID tests will become more sensitive.
With the ongoing mutations that we’re seeing in SARS-CoV-2—the latest, Omicron, has just reached U.S. shores (as of this writing)—it will give rise to more sophisticated tests.
“Already impacting the testing landscape are COVID-19 variant tests that allow for screening for COVID-19 while also allowing the identification of multiple variants of concern/interest in a single reaction,” says Helen Cha Roberts, PhD, President, Seegene Technologies. “The ability to know which variant(s) is circulating in the local population allows for better public health response.”
Prediction #3: Shortages in staff and supplies will continue.
COVID not only will continue to affect testing and the way it must be performed but workflows as well, particularly due to staff shortages and ongoing supply chain issues.
“Staffing shortages have recently affected laboratories and are expected to remain. Retirements and burnout due to increased pressures surrounding COVID testing will likely continue to result in vacancies. Filling these vacancies will be challenging because of shallow applicant pool—fewer graduates of CLS training programs; competition for applicants—and administrative pressures to reduce costs. This will limit laboratory’s ability to expand menus or increase testing complexity,” notes Duane W. Newton, PhD, D(ABMM), FIDSA, Scientific Affairs – Molecular, Quality Systems Division for Bio-Rad Laboratories. “COVID-related stresses on the supply chain resulted not only in unavailability of COVID-related testing supplies and reagents, but also has plagued all areas of the laboratory. Dependence on global sources of these products and reduced capacity to process imported materials through normal shipping channels will exacerbate this situation.”
Prediction #4: Pharmacy-based and at-home testing will continue to grow and be widely accepted.
COVID has changed the testing dynamic, taking it out of traditional hospital or physician office venues, and into pharmacies and consumers’ homes. The experts see this trend continuing and even accelerating into 2022.
“The COVID pandemic opened the door to widespread use and acceptance of pharmacies as critical, convenient and rapid testing and vaccination centers,” notes Blum. The expansion of healthcare services by pharmacy clinics could be an opportunity for IVD companies to provide point-of-care, CLIA-waived tests for rapid, on-site testing at the clinics, and for local laboratories to partner with the pharmacies to provide more comprehensive and esoteric testing services.”
The range of tests available in the home, whether as prescription only test or without a prescription, will also continue to increase, further decentralizing the testing process.
“At-home collection has emerged from the current pandemic to become an important tool beyond COVID-19 detection. Traditionally, diagnostic tests need to be administered by a healthcare provider. At-home collection will allow users the flexibility to perform diagnostic testing from the comfort of the home. A few existing tests, like Cologuard require a prescription, but the at-home collection market will expand, and several exciting new tests will become available without a prescription and purchased online or over the counter,” says Luke T. Daum, PhD, CSO at EKF. “I anticipate the market for home collection to expand exponentially. Novel at-home sample collection and stabilization kits containing optimized media that function beyond simple saline and PBS will be developed for a range of new diagnostic molecular tests.”
Significantly, this trend is probably a genie-out-of-the-bottle moment in which at-home and other non-traditional forms of testing will not go away once the pandemic enters its endemic phase.
“COVID ushered in mobile, point-of-care and at-home diagnostics, along with the growth of telemedicine. These will continue to greatly impact the future of testing,” says Cha Roberts. “At-home diagnostics has made it easier, and more accessible for people to test and receive quick, accurate results. Moving forward, with high-sensitivity molecular tests, people will be able to test themselves, before they even start exhibiting symptoms, with high-sensitivity molecular tests.”
Decentralizing testing either in a neighborhood pharmacy or in a patient’s home will have benefits across the healthcare enterprise, predicts David Wilson, commercial director of diagnostics for Avacta Group plc.
“There is an increasing demand for more patient-centric healthcare, to not only deliver better clinical outcomes but also more cost-efficient healthcare solutions. For example, decentralized testing aims to bring testing out of the hospital laboratory and closer to the patient, and ultimately to point-of-care diagnostics and patient self-testing, to enable the delivery of healthcare where and when it is required,” says Wilson. “With faster turnarounds, test results will be delivered in clinically meaningful timeframes to truly inform clinical and treatment decisions, improving outcomes for patients. Presently, many tests done in the laboratory take time to process, and results are often returned after clinical decisions have already been made. Key applications would be in the rapid prescription of appropriate antibiotics, by quickly knowing that the pathogen is bacterial and its antimicrobial resistance profile, and in wider population screening for early detection of disease, which can make a huge difference in cancer outcomes.”
Further, decentralized testing will democratize the process, taking it out of the hands of specialists, Wilson predicts.
“This decentralized approach requires simple, accurate tests that require little specialist training to use—recent developments with COVID testing and the increased adoption of lateral flow tests for diagnosis, for example, have proven that the technologies are available to deliver these solutions,” he says. “The increased awareness and use of these diagnostics have also shown the capability of non-healthcare specialists to successfully run them. This will lay the groundwork for the adoption of decentralized testing for many other diseases, and potentially fuel the development of self-testing, to enable patients to take more control of their healthcare.”
Prediction #5: The menu of pathogen and genomic tests will increase.
Home testing will give birth to a growing menu of pathogen and genomic tests, according to Daum.
“I anticipate at-home testing to couple with ongoing advancements in molecular pathogen testing and genomic screening/susceptibility tests for cardiac, diabetes and cancer detection. I expect a growing ‘menu’ for biomarker and genomic-based tests in 2022. Users of at-home and over-the-counter tests will be able to monitor and manage chronic conditions before they emerge. The cost of long-read next-generation sequencing continues to become more cost efficient,” says Daum. “Thus, at-home genetic testing will expand in 2022 and beyond, opening attractive markets in bioinformatics where an individual’s genome, obtained from at-home collection can be stored and re-assessed prospectively as new genomics/genotyping tests are developed.”
Prediction #6: Automation, AI, and machine learning will transform laboratory management and workflows.
There are a number of practical reasons why automation and AI will play an increasing role in the laboratory environment.
“Clinical laboratories have played a critical role in response to the COVID-19 pandemic, drawing attention to the work laboratory professionals do as never before[i],” says Xander Van Wijk, PhD, DABCC, FAACC, medical director at Beckman Coulter Diagnostics. “The problems, such as shortage of laboratory technologists and technicians, historic financial pressures on hospitals and health systems, and physically and mentally exhausted laboratory professionals—which existed before the pandemic—have only exacerbated[ii].”
While the labor shortage is a driving force in the rise of AI and automated workflows, Blum also sees wider economic benefits it brings to laboratories and healthcare in general.
“AI and automation will be critically important to help reduce many of the manual processes of lab testing as well streamline logistics and accessioning, and help optimize delivery and use of scare resources due to supply chain issues and increased demand,” he says. “This could also be an opportunity for labs to play a vital role in negotiating better coverage with payers for providing valuable healthcare information—based on lab data—or engage with payers to provide unique services to fill gaps in healthcare.”
The increase of digital pathology will be in driven, in part, by AI, according to Yuri A. Fesko, MD, a board-certified oncologist and Executive Medical Director of Medical Affairs at Quest Diagnostics.
With digital pathology and artificial intelligence FDA cleared to aid in the primary diagnosis of prostate cancer, we expect greater adoption of these technologies in 2022. In 2021, Quest Diagnostics and Paige formed a collaboration to advance AI-generated pathology insights to improve cancer diagnoses and care. After a recent FDA authorization, Paige’s software now has the potential to lay the groundwork for accelerated adoption of artificial intelligence in digital pathology,” says Fesko. “By enhancing the role of the pathologist, digital pathology capabilities with AI can increase access to critical subspecialized expertise, improving accuracy, quality and, ultimately, patient care. In addition, as the pandemic delayed diagnosis of cancers and other diseases, it is likely pathologists will experience an increase in cases requiring their diagnostic expertise in 2022 and beyond. Being forward-thinking in adopting cutting-edge technology like AI is just one way to address both patient and pathologist needs. With advancements in medicine only getting more complex, this technology has the promise to capture the nuances of an individual pathology case via AI pattern recognition of thousands of previous cases to provide better diagnostic insights in areas such as immuno- or biologic- based therapy selection.
Machine learning will also help laboratories meet future and ongoing challenges.
“Machine learning will be an important technology in developing effective molecular diagnostics now and in the future,” says Cha Roberts. “Machine learning-based diagnostics will be the key to simplifying and automating the R&D process, allowing scientists to respond rapidly to testing needs.”
Van Wijk notes that regulatory agencies are, surprisingly, ahead of the curve and are setting guidelines for how technologies need to be developed.
“Expecting a surge in these technologies, the FDA has published 10 guiding principles for Good Machine Learning Practice (GMLP) in the development of medical devices with its regulatory counterparts in Canada and the UK[iii],” he says.
Prediction #7: Diagnostic labs will become critical profit centers for health systems, affiliated hospitals and commercial labs.
During the pandemic, labs have demonstrated their key importance to the entire healthcare enterprise, and will continue to do so in a very specific way, according to Oleg Bess, MD, cofounder and CEO of 4medica.
“Specifically, labs increasingly will focus on realizing the value of the clinical data they generate and hold. The data will be increasingly turned from its muddy state today into gold by following three strategic steps: (1) make it accessible, (2) uniquely identify patients, and (3) create data cooperatives with other labs to derive greater value,” he says. “This quality dataset will improve operational efficiency to boost their financial performance and revenue cycle. It will also generate new revenue when the quality data is utilized by payers, pharmaceuticals, device manufacturers and other healthcare stakeholders. Most importantly, this golden quality dataset will enable patient engagement to a degree that has never been seen before, generating both patient goodwill and additional commercial opportunities for labs.”
Prediction #8: VITAL and IVDR legislation will again be front and center.
The experts see several critical pieces of legislation in the US and beyond back in the spotlight in 2022 that have the capability of changing the way tests are developed.
“With both the Verified Innovative Testing in American Laboratories (VITAL) Act in Congress and In Vitro Diagnostic Regulation (IVDR) on the horizon, laboratory-developed tests (LDTs) are in for a bumpy ride,” says James Shore, MSc, technical product manager at The Native Antigen Company, which is part of LGC Clinical Diagnostics. “Following hurdles to LDT use during the pandemic, Sen. Rand Paul brought a renewed version of his VITAL Act to Congress, which would seek to keep LDT oversight outside of the FDA. On the other hand, the EU’s impending IVDR could create a headache for LDT use, globally. While the effect of IVDR will primarily impact European labs, labs outside of the EU would no longer be able to perform LDTs on specimens from EU citizens without meeting stringent requirements, which would constitute a significant undertaking.”
AMP President Daniel E. Sabath, MD, PhD, notes that passage of the VITAL Act is critical for delivering patient care.
“The coronavirus pandemic has highlighted the inefficient FDA oversight processes and, at the same time, underscored the integral role that public health and local hospital-based clinical laboratories have in both patient care and public health surveillance,” he says. “AMP remains committed to working with Congress and other stakeholders to establish a more efficient regulatory framework that ensures high‐quality patient care while continuing to foster the rapid innovation and promise of new diagnostic technologies. We call on Congress to pass the American Laboratories (VITAL) Act of 2021, which is an important first step to achieving our primary goal of protecting access to the tens of thousands of high-quality, validated LDPs that benefit patients each and every day.”
While the VITAL act is critical in providing tests, according to Sabath, who is also an associate professor and head of hematology for laboratory medicine and pathology at the University of Washington, he also notes there will be ongoing discussions in 2022 on potential amendments to Section 101 of the Patent Act.
“For over 150 years, the Supreme Court has held that laws of nature, natural phenomena, and abstract ideas are not patent-eligible under Section 101 of the Patent Act. In the landmark 2013 Association for Molecular Pathology v. Myriad Genetics case, a fully united Supreme Court ruled in favor of AMP and determined that ‘A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated’,” he says. “AMP predicts that Congress will continue to recognize that the authorization of patents for human genes and naturally occurring associations between genes and diseases would prevent the scientific community from working together to discover novel treatments for common diseases, including cancer, muscular dystrophy, Alzheimer’s disease, heart disease, and other rare and common diseases. It would also create barriers to patients’ access to potentially lifesaving genomic tests and eliminate access to confirmatory testing. Further, these patents would create monopolies that would stifle competition and dramatically increase costs for payers, patients, and the healthcare system overall.”
Prediction #9: New test types will proliferate.
New tests are being researched all the time, and while many show promise, few are brought to market. The experts predict that several new tests will be introduced throughout 2022.
“Liquid biopsy in advanced cancer is likely to increasingly supplement tissue biopsy 2022, becoming an important tool for patients where ensuring a large enough tissue sample for molecular testing is key, especially for cancers like lung,” predicts Fesko. “At the same time, breakthrough innovations like liquid biopsy for cancer detection raise new challenges. If liquid biopsy can identify signals for more possible cancers than current screening methods, what is the best way to help make sure patients, particularly in underserved communities, have access to appropriate work up and confirmatory diagnostics and treatment? In 2022, the medical community, including laboratory professionals, will need to create more solutions to deliver liquid biopsy as part of a care pathway involving multidisciplinary care that connects patients, their primary care team and specialists at each stage of the journey to aid in early diagnosis and potential curative treatment.”
Labs will also have an increasing number of biomarkers at their disposal, says Sabath.
“The number of actionable biomarkers will continue to increase, with a concomitant increase in multi-gene panels using a variety of test platforms. It will be important for us to communicate the clinical validity of these biomarkers to clinicians and payers,” he says.
For his part, Van Wijk singles out a specific assay for cardiac diagnostics that will be introduced in 2022 that will make an impact.
“Highly sensitive cardiac troponin assays will be adopted by most clinical laboratories as recommended by the 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain, which states that “high-sensitivity cardiac troponins are the preferred standard for establishing a biomarker diagnosis of acute myocardial infarction, allowing for more accurate detection and exclusion of myocardial injury[iv],’” he says. “The Society for Academic Emergency Medicine Guidelines for Reasonable and Appropriate Care in the Emergency Department (GRACE) on recurrent chest pain has also recommended that “in adult patients with recurrent, low-risk chest pain, for greater than three hour duration we suggest a single, high-sensitivity troponin below a validated threshold to reasonably exclude ACS within 30 days.[v]’”
Other tests that are on the horizon for 2022 will make testing more affordable, predicts Cha Roberts.
“Syndromic assays will also be an important tool in the future of accurate diagnostics. High-multiplex, syndromic assays available at affordable pricing will allow people to test for more than one pathogen and disease at a time, making testing and follow-up care more efficient, timely and effective,” she says. “Because these assays are developed through data-driven logic and automation, they are often remarkably accurate and provide a complete picture of a patient’s health status in a clinically meaningful timeframe to reach therapeutic decisions.”
Prediction #10: New technologies focused on antibody levels will gain traction.
The growing interest in both the importance of and how to measure antibody levels post-COVID infection or vaccination will spur a new category of tests, says Iswariya Venkataraman, PhD, associate director of scientific affairs for EUROIMMUN US, a PerkinElmer company.
“In such a rapidly evolving and changing environment, the development of surrogate virus neutralization tests that can detect neutralizing antibodies against the spike protein of SARS-CoV-2 is fortunately gaining steam. These assays can be completed in 1-3 hours without the need for Biosafety Level 3 facilities or live virus or cells, making them accessible in both research and clinical applications,” she says. “Currently, the FDA has granted emergency use authorization for two of the surrogate virus neutralization tests for its use in in-vitro diagnostics against SARS-CoV-2, and there likely will be more advancements in the upcoming months and years. Such tests may help support vaccine efficacy evaluation, herd immunity, protective immunity assessments and more.”
She sees this development as having an impact both in the short- and long-term.
“The ability to measure neutralizing antibody against a virus accessible to all scientists and researchers without the need for complex laboratory facilities, resources and equipment will be a significant advancement in testing for infectious diseases during and post-COVID-19,” she says.
Prediction #11: The diagnostic backlog will make 2022 a busy year for clinical labs.
Numerous studies have shown that among the other negative effects of the COVID-19 pandemic, many patients put off routine diagnostic tests. With the world opening up again, patients and care providers will be attempting to “catch up” and this will cause more work for already overburdened clinical laboratories.
“To prevent a secondary health crisis, labs will have to meet a surge in diagnostic demands through 2022. Cancer screening services, for example, were delayed or suspended in many labs, leading to a significant under-diagnosed population, with the potential for worse prognoses,” says Shore. “Combined, the effect of lockdowns has reduced population immunity to many seasonal infectious diseases, such as influenza and norovirus, making outbreaks both more likely and significant.”
Prediction #12: Labs will work together for more reasonable coverage and better reimbursement for diagnostic tests.
Along with other legislative action, the industry will need to come together to address the challenges related to coverage and reimbursement, says Sabath.
“Impending cuts to the Clinical Laboratory Fee Schedule and issues with the implementation of the Protecting Access to Medicare Act (PAMA) must be addressed with key stakeholders in 2022,” he says. “AMP looks forward to working with all interested parties to help ensure adequate reimbursement that provides more patients with better access to these valuable test procedures.”
Prediction #13: Testing menus will increase on a limited basis.
For many labs, COVID saw a need to expand their testing capabilities. With the pandemic poised to enter an endemic phase, the ongoing need for this equipment will have to be justified—a potential challenge for laboratory managers.
“As COVID testing volumes decline, there will be increased desire to identify additional menu options to justify maintaining possession of these platforms,” says Newton. “While new testing options—assays, reagents—may be available, pressures resulting from staffing shortages will likely limit the ability of laboratories to implement new tests.”
Prediction #14: Disruptive technologies will allow more people to receive diagnostic tests.
While a large population of patients skipped or delayed routine testing during the pandemic, an equally or even larger population didn’t have access to diagnostic tests before the pandemic began—a condition, which continues today. Chockalingam “Palani” Palaniappan, PhD, chief innovation officer at Ortho Clinical Diagnostics, predicts this will begin to change starting in 2022.
“Although 70% of all healthcare decisions derive from in vitro diagnostic testing today, less than half of the world’s population has access to standardized testing, even for prevalent, devastating conditions like diabetes, hypertension, HIV, and TB,” he says. “As the world’s population grows to a projected 11 billion people by 2050 and demands on the global healthcare system continue increasing, I expect much of need will be fulfilled through the adoption of disruptive innovations such as environmentally sustainable, waterless systems that are capable of providing diagnostic testing in remote geographies where a lack of infrastructure might otherwise inhibit patients’ access. Helping more people get the crucial diagnostic testing they need would accelerate diagnoses and treatment, which could tremendously impact global rates of chronic and infectious diseases.”
Prediction #15: Collaboration will become the industry norm.
The past two years have seen increased collaboration among researchers, government agencies, and providers. Arvind Kothandaraman, managing director, specialty diagnostics for PerkinElmer, expects that to continue into 2022.
“COVID-19 has urged scientists to work more creatively and collaboratively than ever before. For decades, public-private partnerships have demonstrated tremendous value in the areas of newborn screening, food, and water testing,” says Kothandaraman. “Today, and for years to come, such foundational collaborative efforts will be critical in the fight against forces that pose a threat to global health. As COVID-19 transitions to an endemic disease, we’ll see a concerted effort within and across scientific communities, governments, and other vested parties to prevent future pandemics. A global surveillance model for timely identification, tracking, and mitigation of future outbreaks is an eagerly expected outcome in 2022.”
Collaboration won’t just end with managing COVID-19.
“Beyond pandemic management and prevention, collaboration will further propel important discoveries in the field of personalized medicine,” says Kothandaraman. “Using next generation sequencing, scientists are learning more each day about the human genome and how certain genetic variants may make a person more likely to develop certain diseases or conditions. This advancement has already armed clinicians with information to improve patient care, including recommendations that have proved to be lifesaving.
A collaborative approach will also be a means to fulfill many of the other predictions for 2022.
“A collaborative mentality also has high potential to accelerate vast improvements in operational aspects including availability, accessibility, ease of use and automation to maximize the impact of healthcare solutions,” says Kothandaraman.